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康哲藥業(00867.HK):甲氨蝶呤注射液(預充式)獲藥物臨牀試驗批准通知書
格隆匯 08-13 21:32

格隆匯8月13日丨康哲藥業(00867.HK)公吿,集團於2020年9月21日從medac Gesellschaft für klinische Spezialprparate m.b.H("medac")授權引進的創新藥甲氨蝶呤注射液(預充式)("產品")獲得中華人民共和國國家藥品監督管理局於2021年8月13日簽發的藥物臨牀試驗批准通知書,同意產品開展成人類風濕關節炎(RA)適應症臨牀試驗。該試驗是一項以甲氨蝶呤口服制劑為對照的非劣效設計臨牀試驗,以便評估產品在中國RA患者中的安全性和有效性。

產品為多種規格的低劑量小容量甲氨蝶呤注射劑,擬用於治療成人活動性RA和其它自身免疫性疾病,並已獲得歐洲藥品管理局總部(HMA)批准上市。甲氨蝶呤是國際公認的RA系統性治療的一線金標準藥物。中國目前沒有用於治療RA的甲氨蝶呤注射劑(含預充式)獲批上市。產品有望成為中國首個以皮下給藥治療RA的甲氨蝶呤藥物,滿足RA患者基礎治療的用藥需求。

集團正積極準備開展相關臨牀試驗工作。

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